Regulatory Consultant, CMC

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

United Kingdom,London,London,

Key Skills :

cmc, manager, consultant, contract, consultant, biologics

Salary :

£50 - £70 per hour

Date Posted :

18 Sep, 2019

Company Name :

Key People

Location1 :


Job Category :

Regulatory Affairs Jobs

Experience :


Job Type:


Travel Amount:



An excellent opportunity has arisen for an experienced CMC specialist to join a CRO on an initial 6-12 month contract basis. Excellent rates and 100% home working are on offer! Previous biologics experience is ESSENTIAL for this role.

*Accountable for file-ability and approvability of CMC clinical (CTA/IND) and commercial filings through involvement at all steps of dossier authoring, review, approval
*Develop global Regulatory CMC strategies for client's biologics products to facilitate overall program goals.
*Provide regulatory CMC expertise on cross-functional project teams working with suppliers and contract manufacturers as required in order to ensure alignment of development and implementation of activities with overall regulatory CMC strategies.
*Actively manage complex CMC regulatory submissions and ensuring quality and timelines are met for all pre and post approval biologics submissions.
*Manage regulatory CMC aspects of post approval change controls, liaising with stakeholders to ensure regulatory compliance. Responsible for recommending the appropriate regulatory reporting mechanism, in liaison with regional regulatory experts.
*Lead the preparation of CMC aspects of documents for regulatory agency interactions and may represent Regulatory CMC in agency meetings.
*Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
*Participate in regulatory intelligence activities as they pertain to global CMC regulations and guidance for biologics, and provide regulatory advice to project teams
*Create high quality reports and other outputs according to the defined specifications to ensure timely reporting of assigned job to project management.

Experience Required:
*A minimum of a graduate degree in Life Sciences
*Candidates with experience in pre and post approval biologics CMC, including for monoclonal antibodies, insulin products regulatory filings.
*Biosimilar experience would be an advantage
*Significant knowledge on Biologics regulatory requirements and/or guidelines and exposure to relevant document management systems and publishing tools are preferred.
*Significant knowledge of ICH guidelines and BLA submission requirements of various markets such as USFDA, EMA etc.

For further details, please contact Tim Barratt on 01727 817626 or send a copy of your CV to

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit

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